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An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE2

An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients

NCT00918177•Intec Pharma Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate blood level profiles of multiple oral doses of AP09004 vs. active control and to determine its safety and efficacy in Parkinson's patients.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects between the ages of 18 and 75 years of age inclusive;
•For early patients only: Subject with Parkinson's disease with a stable response to Levodopa (not suffering from "wearing off") and currently treated with IR-Carbidopa/Levodopa containing 300-500mg Levodopa per day up to 4 doses per day.
•For group 3 only: Subject with Parkinson's disease experiencing predictable motor fluctuations, end of dose "wearing off", defined by the patient's report of at least two episodes daily of a decline in function from peak benefit, with at least 2-3 hours OFF a day at the discretion of the PI (does not include early morning akinesia). Only patients with end of dose wearing off for at least 3 months will be included.
•For moderate patients only: patients who are currently treated with IR-Carbidopa/Levodopa containing 600-900mg Levodopa, in divided dose, per day.
•Subject has been stable at current CD/LD dose for at least 1 months
•Hoehn and Yahr stages I-III
•If subject is taking dopamine agonists, the dose has been stable for at least 1 month
•Other then Parkinson's disease, the subject is in satisfactory health, as assessed by physical examination, blood test (biochemistry and hematology). No abnormality on clinical examination and blood tests that in the opinion of the Physician responsible will compromise safety or interfere with study procedures.

Exclusion Criteria

•Subjects who have participated in another clinical trial within the last 30 days;
•Subjects with atypical Parkinsonism
•Subject has significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the physician responsible, contraindicates his/her participation.
•Subject with symptomatic gastroparesis with frequent vomiting (at least once a week).
•Subjects with a history of clinically defined GERD, peptic ulcer or any gastrointestinal surgery other than appendectomy or herniotomy, or with any gastrointestinal disorder likely to influence drug absorption, or with any history of inflammatory bowel disease, irritable bowel syndrome, severe gastrointestinal narrowing, or frequent nausea or emesis, regardless of etiology.
•Prior gastro-intestinal surgery or current gastrointestinal conditions of clinical significance including ulcers, diarrhea, vomiting, bleeding, intestinal obstruction or inflammatory bowel disease, which, in the opinion of the physician responsible, contraindicates his/her participation.
•History of drug or alcohol abuse.
•Subject has a history of allergy to any component of the dosage form or any other allergy, which, in the opinion of the physician responsible, contraindicates his/her participation.
•Subjects suffering from psychological disorders that in the opinion of the physician responsible may interfere with full participation.

Locations (7)

Barzilai Medical Center, Department of Neurology, Movement disorders unit,

Ashkelon, Israel

Department of Neurology, Clalit University Medical Center

Beersheba, Israel

Rambam Health Care Campus, Haifa, Movement Disorders and Parkinson's Disease

Haifa, Israel

Edith Wolfson , Dept. of Neurology, Movement Disorders Unit.

Holon, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

TASMC

Tel Aviv, Israel

Key Dates

Start Date

July 1, 2009

Primary Completion Date

October 1, 2012

Last Updated

May 28, 2014

Enrollment

ESTIMATED participants

Conditions

Parkinson's Disease

Interventions

AP09004

DRUG

Carbidopa/Levodopa, immediate release

DRUG

Deep Brain Stimulation Therapy in Movement Disorders

NCT02119611

Parkinson's Disease

View study

RECRUITINGPHASE1

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

NCT07310264

Healthy Volunteers (HV)Parkinson's Disease (PD)

View study

RECRUITINGNA

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Deep Brain Stimulation Therapy in Movement Disorders

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD) China Study

A Study to Evaluate the Efficacy and Safety of Intravenous (IV) Prasinezumab in Participants With Early-Stage Parkinson's Disease

Effect of Striatal Temporal Interference Stimulation on Language Processing in Neurodegenerative Diseases

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations